The effects of hybrid cycle exercise training in inactive people with a chronic spinal cord injury.

People with a chronic spinal cord injury are often physically inactive and
suffer from different secondary complications (e.g. cardio-vascular diseases,
osteoporosis and pressure sores), resulting in a decreased mobility,
participation and quality of life. Avoiding this downward spiral is therefore
crucial. Physical exercise can have benificial effects on different secondary
complications, activity level, quality of life and participation.
Therapeutic exercise for individuals with spinal cord injury (SCI) has
traditionally involved upper-body activities due to their lower-limb paralysis.
However, systematic disuse of the lower body leads to secondary complications
such as lower-limb muscle atrophy, osteoporosis and pressure sores.
Reactivating the inactive lower body by functional electrical stimulation (FES)
has the potential to alleviate these problems. A major advantage of electrical
stimulated (ES)-induced exercise of the paralyzed legs over voluntary arm
exercise is that it can utilize a large muscle mass that otherwise would be
dormant. Recent technological developments have introduced a hybrid tricycle
(Berkelbike) where ES-induced lower-body exercise can be combined with
voluntary upper-body exercise. This study evaluates the effects of a 16-week
hybrid cycle training program by comparing this program with a 16-week hand
cycle training program and a non-training group.

The primary objective is to evaluate the short- and long-term effectiveness of
a hybrid cycle training program on physical capacity, active lifestyle,
participation, and quality of life among a group of inactive individuals with a
chronic SCI. Furthermore, the effects on *disuse and inactivity*-related
measures such as skin, muscular, bone and vascular characteristics among these
people are studied.

Multicentre randomized controlled trial

A 16-week training intervention on a hybrid cycle or hand cycle. Both
experimental groups will train 2x/week, 30 min. on 70%HRR. The control group
will not receive any training.

Subjects will participate in a 10-month (including a 6-month follow-up period)
research project, where the experimental groups execute a 16-week training
program on a hybrid cycle or on a hand cycle (2x30 min/wk, 70%HRR).
Measurements will be performed before the start of the training (pre-test),
after 8 weeks of training (mid-test), directly after the training (post-test),
and 26 weeks after the post-test (follow-up test). Measurements will include
(sub)maximal exercise testing, cardiovascular and neuromuscular function tests,
as well as daily functioning and quality of life and participation. Since both
hand cycling and hybrid cycling involve a large muscle mass and balanced
loading, it is not expected to cause overload injuries when training at 70%HRR.
The graded exercise tests in the wheelchair and in the specific set-up (either
a hybrid cycle or a hand cycle) might lead to local discomfort of the upper
extremity during the test and/or muscle soreness after the test. However,
comparable research with hybrid cycle and hand cycle training in people with
SCI showed no serious musculoskeletal complaints during training and testing.
Furthermore, the risks during training and testing sessions are relatively low
because of thorough screening prior to participation and safety precautions
throughout training and testing. The expected beneficial training effects in
combination with the limited risks would justify execution of the proposed
study.